Contract Development Online Training Industry Overview. Published by Pharma IQ Sector Report & Resources July 2011 Contents: + Increasing transparency in clinical outsourcing + Balancing Ethics with Economy in + Outsourced Clinical Trials + India Looks to a Future in Clinical Trials + Additional Resources + Contract Development Online Training https://www.clinicalcontractdrafting.com/index.cfm?&shownewswindow=1&utm_source=PharmaIQ&utm_medium=SMO&mac=PMIQ_Slideshare&utm_campaign=Slideshare&utm_term=pdf

1. Contract Development Online
Training
Industry Overview
Pharma IQ
Sector Report & Resources
July 2011
Contract Development Online Training
Pharma IQ Sector Report & Resources 2011

2. Contents
3. Increasing transparency in clinical outsourcing
5. Balancing Ethics with Economy in Outsourced Clinical Trials
7. India Looks to a Future in Clinical Trials
9. Additional Resources
11. Contract Development Online Training
Authors: Andrea Charles | Cristina Falcao| Helen Winsor
Pharma IQ 2010 - 2011
Contract Development Online Training
Pharma IQ Sector Report & Resources 2011

3. Increasing transparency in clinical outsourcing
In the pharmaceutical industry, the majority of companies now outsource the clinical
trial process, with a massive 67 per cent of pharma and bio organisations outsourcing
more than half of their trials.
Companies recognise that clinical development is both unpredictable and timeconsuming,
and it is estimated that inefficiencies in the process lead to seven out of
ten trials being delayed or cancelled, at a cost of $1.1 million (£680,000) in daily
prescription revenues.
As a result, many organisations are focusing on establishing contract research
organisation (CRO) accountability, running trials in emerging markets and entering
into risk-sharing partnerships as potential, albeit risky, means of smoothing this
process. However, an obstacle for many is a lack of transparency and consistency in the global
clinical outsourcing process – an issue recently addressed by SOMO, a Dutch nonprofit
organisation.
A recent article in Outsourcing Pharma highlighted how SOMO is calling for a global
compulsory register of all contractors and subcontractors involved in each clinical
trial to be created for this purpose.
This is because the evolution of the outsourcing and offshoring of clinical trials has
led to concerns that regulators have failed to keep up with changes and has increased
the focus on the efforts made by CROs and sponsors to self-regulate conduct in these
trials.
The SOMO report explained: "It remains an area of grave concern that the parties that
earn most money with the trials - CROs and sponsors - seem to be the most important
monitors in non-traditional trial regions".
In order to make the process more transparent, the organisation recommends the
creation of a worldwide compulsory trial register, in which all parties involved in the
trial are disclosed, including any contractors and subcontractors.
Such a measure would help to build on national and international trial registry
initiatives and explain any grey areas, the firm claims.
In particular, including subcontractors in the register would address concerns about
the impact of CRO outsourcing work, as SOMO claims that CRO "fragments clinical
trial-related tasks further" and could lead to "a lack of comprehension of the full trial
process".
A survey of sponsors carried out by the organisation found that CROs need to inform
them when subcontractors are used, as in many instances prior consent is required,
while concerns about regulators are also lingering.
Contract Development Online Training
Pharma IQ Sector Report & Resources 2011

4. The SOMO study noted that there was a distinct unwillingness to share information
and the company expressed its concern at the "extreme lack of transparency of CROs
in particular and of the pharmaceutical sector in general".
Some of the other recommendations in the report included increasing overseas
inspections and including participants' views in inspections and audits, as well as
making independent verification of Declaration of Helsinki compliance part of
marketing authorisation applications.
According to the Dutch firm, it began research on the report expecting to find
pharmaceutical research and development outsourcing shared problems with other
sectors, but it found both unique and existing and potential problems, such as the
lowering of standards due to cost and competition pressure.
In order to ensure that CROs meet both legal and ethical standards, sponsors say they
have developed mechanisms which select, monitor and evaluate outsourcing partners.
As a result, measures to protect patients are now in place, but further reassurance of
independent oversight is needed.
Last year, a report by the Association of Clinical Research Organisations (ARCO)
into overseas clinical trials found that CROs have taken steps to ensure that both
quality and ethical standards are the same in all countries in which they operate, and
now a further study is in the pipeline.
At the time, John Lewis, vice president of public affairs at ACRO, commented: "A
preliminary study of multinational trials sponsored by ACRO demonstrates that there
are no quality differences across or among regions.“
It is clear that sponsors and pharmaceutical organisations alike feel that boosting
transparency in the clinical outsourcing trial process would be of benefit to all
members of the sector in the long term, by cutting daily prescription revenues and
ultimately shortening time to market.
Contract Development Online Training
Pharma IQ Sector Report & Resources 2011

5. Balancing Ethics with Economy in Outsourced Clinical Trials
Concerns are frequently raised in the pharmaceutical industry over the danger that when clinical
trials are outsourced to contact research organisations (CROs), ethical protections might take a
backseat to quicker and cheaper new product development. Outsourcing of trials to CROs and
offshoring to developing economies, emphasises the need for independent monitoring and
compulsory registration.
This argument was put forward in a recent report by Dutch non-profit group SOMO (Centre for
Research on Multinational Corporations), which was dismissed by some in the industry for being
full of criticism and concern, but lacking in firm evidence of harm caused by lax regulatory
oversight or insufficient exercise of sponsor responsibilities.
The paper slammed an "extreme" shortage of transparency among CROs and the pharmaceutical
industry as a whole. As a result, the authors admitted that some of their findings "remain
anecdotal and thus any generalisations … should be avoided". Accordingly, they advised
interpreters of the report to view it more as a "discussion document", as opposed to conclusive
evidence of the issues it seeks to address. However, it did set out a number of recommendations
as to how the transparency and oversight of clinical trials in "non-traditional regions" might be
improved.
As a starting point, SOMO suggested that a worldwide, compulsory clinical trial register should
be set up, disclosing all parties involved in each study, including all contractors and subs. Next on
its list of recommendations was an increase in the number of inspections at trial sites in so-called
non-traditional areas. It was also proposed that audit results should be made publicly available
with a view to achieving 100 percent transparency.
Published in February 2011, the report stems from an observation that roughly half of all clinical
trial activities are now being outsourced to CROs, with a resulting market value of approximately
$24 billion (£14.7 billion) last year. And cost pressures, along with the challenges faced when
recruiting for trials, are pushing an increasing number of studies into Latin American countries,
China, Eastern Europe and Russia. The authors cited a number of widely-recognised commercial
advantages as potential reasons for the popularity of such regions when it comes to conducting
trials. These include speedy recruitment, a broad spectrum of diseases and wide availability of
human resources and technical skills. At present, it is thought that between 40 and 50 per cent of
new drug applications submitted in Europe and the US include trials carried out in these areas.
In addition to the growing presence of CROs in popular clinical trial destinations, large markets
like India and Brazil have seen regulatory processes modified in recent times, to expedite
approvals. This, SOMO claimed has been a "decisive factor" in attracting the contract research
sector. It was suggested that CROs can go about their business in these regions without
accreditation.
Contract Development Online Training
Pharma IQ Sector Report & Resources 2011

6. But some have argued that medical ethicists simply use reports like the one from SOMO to
insinuate that pharmaceutical companies deliberately conduct foreign trials to avoid more
stringent constraints on home turf and to experiment on unsuspecting patients. Writing in the
Washinton Examiner last year, two University of Chicago professors said that these concerns
were "exaggerated and ignore the complexities of modern clinical research".
Thomas Philipson and Anup Malani explained that if the US Food and Drug Administration
(FDA) were to push companies towards conducting more trials domestically, overseas patients
would lose the "often valuable" health benefits sometimes associated with clinical research. At
the same time, consumers in the US would endure slower access to new, potentially life-saving
treatments, they argued.
There is certainly reason to examine the need for a balance of ethics with economies when
itcomes to conducting clinical trials offshore. But it seems the advantages of outsourcing
experiments to non-traditional locations, which at present hold the key to that much sought after
productivity, will see the presence of CROs in developing markets continue to grow for years to
come.
Contract Development Online Training
Pharma IQ Sector Report & Resources 2011

7. India Looks to a Future in Clinical Trials
If the recent recession highlighted anything to firms in all sectors, it was how important
it is for them to focus on their core competencies. On occasion, companies can be led
away from their primary concern or speciality, which in turn can impact on their success
and financial security.
Such issues are prevalent in the competitive world of pharmaceuticals, where drug
developers must work quickly to produce new products and innovate as quickly as
possible. As a result, it is often time-consuming for them to carry out certain tasks, such
as clinical trials, themselves.
Outsourcing has become a key way around such obstacles, with the market for such
services developing quickly to become a global proposition. Firms are no longer simply
looking to work with other businesses in the same country, as many emerging markets
have become potentially more suitable to their needs.
One country which provides evidence of this shift in attitude to trial outsourcing is
India. Research by market intelligence body RNCOS has revealed that new measures
included in the country's latest budget could lead to major growth in the Indian clinical
trial market.
The Booming Clinical Trials Market in India report suggested that global drugs
companies could boost their spending on research and development projects in the
country by between 25 and 50 per cent, which in turn would see the market enjoy a
compound annual growth rate of 31 per cent in the next two years.
According to the study, interest in India can be linked to several issues. The country has
a large patient pool with both chronic and infectious diseases, meaning recruitment for
trials is theoretically easier than in other areas. In addition, the operation of trials is
possible at a lower cost.
"Moreover, the changing regulatory environment and introduction of a patent regime
has also given a significant boost to the Indian clinical trial market," the report added.
Contract Development Online Training
Pharma IQ Sector Report & Resources 2011

8. Other notable aspects of the study include, the discovery that clinical trials in India are generally
conducted by either government or private hospitals, while preliminary enquiries also highlighted
there are a number of firms and agencies exclusively operating such projects in the country.
So while India has emerged as a strong contender in the clinical trials industry due to its patient
pool and cost savings, are there any other benefits the country is offering to the biggest names in
pharma? Dr Saral Thangam, technical director of Lotus Clinical Research Academy, told
PharmaBiz.com that the personnel on offer in the region are often attractive to companies.
She explained to the website that businesses have high levels of confidence in the qualified
employees on hand, particularly pharmacy graduates and doctors. The fact that many of the staff
can speak and write English has also put India ahead of other emerging nations, she added, as
such a skill set is not always available in countries like China.
However, Sudhir Pai, managing director of Lotus Clinical Research Academy, told the website
that such interest should not be considered as evidence that only companies from the western
world are keen on launching operations in the country.
He outlined that hopes are high that Japan, one of the biggest pharmaceutical markets in the
world, could soon transfer much of its own clinical work to the area in the near future.
India has undoubtedly become a key example of how the outsourcing of clinical trials is now very
much a global proposition. With more companies across the globe looking to improve their drug
development operations, it is likely that the country - and a number of other emerging nations -
will benefit from a welcome boost in the aftermath of the global economic downturn.
While such growth will be useful to many pharmaceutical firms, relationship management issues
and strategies linked to partnering with overseas organisations will rise up the agenda for a large
number of them. The world is opening up for drugs developers, but they will need the correct
skills to take advantage.
Contract Development Online Training
Pharma IQ Sector Report & Resources 2011

9. Additional Resources
INTERVIEW: Logistics for Clinical Trials in Emerging Markets
With Mark Walls, Director of Clinical Pharmacy at Human Genome Sciences
Mark Walls, Director of Clinical Pharmacy at Human Genome Sciences, speaks to
Andrea Charles from Pharma IQ, about the logistical challenges facing clinical
trials and avoiding common mistakes for logistics in emerging countries. He also
talks about the need for pharmaceutical and biotech companies to optimise logistics
and overcome inefficiencies in the clinical supply chain.
ARTICLE: Bringing Innovation to Clinical Design
Clinical trials may be one of the most fundamental parts of drug development
work carried out in the pharmaceutical industry, but they still remain a
complicated area for pharma companies to address. The design of trials plays an
important role in the process of producing the right kind of data to support
applications and ensure that products take a strong step towards reaching market. I
INTERVIEW: Clinical R&D on the Move Towards India
With Dr. Rajendra Jani, Senior Vice President at Zydus Cadila
Dr. Rajendra Jani, Senior Vice President at Zydus Cadila, shares his insights with
Pharma IQ, about current trends in the global clinical market, the shift towards
clinical R&D in India and how to improve the efficacy and efficiency of clinical
trials.
Contract Development Online Training
Pharma IQ Sector Report & Resources 2011

10. Glossary
Clinical Contract Development and Trial
Event
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Agenda
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Module 1 - Identification of Needs and Providers
Background: Course Outline & Industry Overview
Meet Your
Determining Scope
Speakers
Comparison of strategic vs. tactical engagements
The Clinical Team’s Role in the end-to-end Contracting Process
Module 2 - Vendor Selection: The RFP Process Pricing
RFP Components
Optimizing the RFP Process for Effective Vendor Selection Register
Module 3 – Contracts: Focus on Oversight & Governance Today
RFP Components
Optimizing the RFP Process for Effective Vendor Selection
Module 4 – Contracts: Focus on Legal Terms & Conditions
Key legal terms and conditions
Negotiating legal terms and conditions
Module 5 - Contracts: Focus on Financial
Budget Types and Examples
Payment Schedule Types and Examples
Negotiating budgets and payment schedules
Module 6 - Contracts: Tying It All Together
The contract as a blueprint to an outsourcing engagement
Actively managing to the contract
Change management
Contract Development Online Training
Pharma IQ Sector Report & Resources 2011